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NCT02794246 · ClinicalTrials.gov registry record · Phase 2
CART-19 Post-ASCT for Multiple Myeloma
A Phase 2 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT02794246: Clinical Trial Phase 2 study, sponsored by University of Pennsylvania.
NCT02794246 is a Phase 2 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02794246, a Phase 2 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This will be a single-arm, open-label study. Patients will be enrolled during induction therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to ASCT, and CART-19 will be infused at day \~60 post-ASCT, 3 days after lymphodepleting chemotherapy. The primary endpoint is progression-free survival (PFS) after ASCT. As detailed below, the study is powered to detect an increase in two-year PFS to \~75% from a baseline expectation of 55% based on historical data. Secondary endpoints will evaluate CART-19 persistence and function, minimal residual disease, immune correlative endpoints, and associations of progression-free survival (PFS) with CART-19 persistence and clinical and biologic characteristics of multiple myeloma.
Interventions
- BIOLOGICAL CART-19 cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02794246
The ClinicalTrials.gov registry entry for NCT02794246 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CART-19 cells is the first listed.
NCT02794246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02794246 about?
NCT02794246 is a clinical study titled "CART-19 Post-ASCT for Multiple Myeloma". This will be a single-arm, open-label study. Patients will be enrolled during induction therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to ASCT, and CART-19 will be infuse...
What is the current status of trial NCT02794246?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2016-06. Estimated completion is 2019-05.
What interventions are being tested in trial NCT02794246?
The interventions under investigation include: CART-19 cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02794246?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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